Headless Screw System 401-20324

GUDID M695401203240

Headless Ø2.0 x 24mm Long Thread Ti (Torx)

Tyber Medical, LLC

Orthopaedic bone screw (non-sliding)

• Primary Device ID: M695401203240
• NIH Device Record Key: 3aecac81-83a2-4fbd-8301-17bc85fa508e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Headless Screw System
• Version Model Number: 401-20324
• Catalog Number: 401-20324
• Company DUNS: 010968002
• Company Name: Tyber Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M695401203240 [Primary]
HIBCC	M695401203241X [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133842

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M695401203240]

Moist Heat or Steam Sterilization

[M695401203240]

Moist Heat or Steam Sterilization

[M695401203240]

Moist Heat or Steam Sterilization

[M695401203240]

Moist Heat or Steam Sterilization

[M695401203240]

Moist Heat or Steam Sterilization

[M695401203240]

Moist Heat or Steam Sterilization

[M695401203240]

Moist Heat or Steam Sterilization

[M695401203240]

Moist Heat or Steam Sterilization

[M695401203240]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-08-15
• Device Publish Date: 2025-01-23

On-Brand Devices [Headless Screw System]

• M695401303160: Headless Ø3.0 x 16mm Long Thread Ti (Torx)
• M695401303150: Headless Ø3.0 x 15mm Long Thread Ti (Torx)
• M695401303140: Headless Ø3.0 x 14mm Long Thread Ti (Torx)
• M695401303130: Headless Ø3.0 x 13mm Long Thread Ti (Torx)
• M695401303120: Headless Ø3.0 x 12mm Long Thread Ti (Torx)
• M695401303110: Headless Ø3.0 x 11mm Long Thread Ti (Torx)
• M695401303100: Headless Ø3.0 x 10mm Long Thread Ti (Torx)
• M695401302400: Headless Ø3.0 x 40mm Short Thread Ti (Torx)
• M695401302350: Headless Ø3.0 x 35mm Short Thread Ti (Torx)
• M695401302340: Headless Ø3.0 x 34mm Short Thread Ti (Torx)
• M695401302330: Headless Ø3.0 x 33mm Short Thread Ti (Torx)
• M695401302320: Headless Ø3.0 x 32mm Short Thread Ti (Torx)
• M695401302310: Headless Ø3.0 x 31mm Short Thread Ti (Torx)
• M695401302300: Headless Ø3.0 x 30mm Short Thread Ti (Torx)
• M695401302260: Headless Ø3.0 x 26mm Short Thread Ti (Torx)
• M695401302250: Headless Ø3.0 x 25mm Short Thread Ti (Torx)
• M695401302240: Headless Ø3.0 x 24mm Short Thread Ti (Torx)
• M695401302230: Headless Ø3.0 x 23mm Short Thread Ti (Torx)
• M695401302220: Headless Ø3.0 x 22mm Short Thread Ti (Torx)
• M695401302210: Headless Ø3.0 x 21mm Short Thread Ti (Torx)
• M695401302200: Headless Ø3.0 x 20mm Short Thread Ti (Torx)
• M695401302150: Headless Ø3.0 x 15mm Short Thread Ti (Torx)
• M695401302120: Headless Ø3.0 x 12mm Short Thread Ti (Torx)
• M695401302110: Headless Ø3.0 x 11mm Short Thread Ti (Torx)
• M695401302100: Headless Ø3.0 x 10mm Short Thread Ti (Torx)
• M695401204340: Headless Ø2.0 x 34mm Full Thread Ti (Torx)
• M695401204330: Headless Ø2.0 x 33mm Full Thread Ti (Torx)
• M695401204320: Headless Ø2.0 x 32mm Full Thread Ti (Torx)
• M695401204220: Headless Ø2.0 x 22mm Full Thread Ti (Torx)
• M695401204210: Headless Ø2.0 x 21mm Full Thread Ti (Torx)
• M695401204200: Headless Ø2.0 x 20mm Full Thread Ti (Torx)
• M695401203350: Headless Ø2.0 x 35mm Long Thread Ti (Torx)
• M695401203240: Headless Ø2.0 x 24mm Long Thread Ti (Torx)
• M695401152300: Headless Ø1.5 x 30mm Short Thread Ti (Torx)
• M695401152230: Headless Ø1.5 x 23mm Short Thread Ti (Torx)
• M695401152220: Headless Ø1.5 x 22mm Short Thread Ti (Torx)
• M695401152210: Headless Ø1.5 x 21mm Short Thread Ti (Torx)
• M695401152200: Headless Ø1.5 x 20mm Short Thread Ti (Torx)
• M695401152140: Headless Ø1.5 x 14mm Short Thread Ti (Torx)
• M695401152130: Headless Ø1.5 x 13mm Short Thread Ti (Torx)
• M695401152120: Headless Ø1.5 x 12mm Short Thread Ti (Torx)
• M695401152110: Headless Ø1.5 x 11mm Short Thread Ti (Torx)
• M695401152100: Headless Ø1.5 x 10mm Short Thread Ti (Torx)